At a Glance
- Tasks: Lead the UKI Quality & Regulatory Affairs team and ensure compliance with regulations.
- Company: Join Medtronic, a leader in global healthcare technology.
- Benefits: Competitive salary, flexible benefits, and a commitment to employee well-being.
- Other info: Dynamic role with opportunities for career growth in a supportive environment.
- Why this job: Make a real impact on health solutions while developing your leadership skills.
- Qualifications: Experience in Regulatory Affairs and strong leadership abilities required.
The predicted salary is between 71760 - 107640 £ per year.
The Quality & Regulatory Affairs Manager for the UK and Ireland is responsible for regulatory compliance, post‑market surveillance, and quality system compliance to ISO 13485 for Medtronic Ltd. This role leads the UKI QRA team and serves as the primary contact with UK and Irish regulatory agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Products Regulatory Authority (HPRA), and relevant Health Technology Assessment (HTA) bodies. The Manager provides regulatory expertise for local projects and ensures compliance with UK and EU requirements.
Responsibilities
- Lead and develop the UKI Quality & Regulatory Affairs team
- Own and maintain UKRP, Human Tissue Import Licence, and BioPharma Import Licence activities for Medtronic Ltd, acting as the main contact for relevant authorities
- Monitor regulatory changes across the UK and EU, assess impact, and drive updates to regional and local procedures
- Coordinate internal and external audits and inspections
- Maintain ISO 13485 certification
- Oversee Post‑Market Surveillance activities in the UK and Ireland, including field safety corrective actions, notifications, execution reporting, and responses to MHRA and HPRA requests for additional information
- Deploy enterprise QRA strategy and initiatives across UKI
- Provide and/or coordinate local training on regulatory affairs and quality topics
Required Knowledge and Experience
- Significant experience in Regulatory Affairs and Quality within the medical device industry
- Proven leadership and people development experience
- Strong communication, interpersonal, and influencing skills
- Hands‑on, rigorous approach with strong analytical and strategic thinking abilities
- Solid organizational and project management skills
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Pay range: United Kingdom: £71,760.00 - £107,640.00. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
Regulatory Affairs Manager Watford employer: Medtronic
Medtronic is an exceptional employer, offering a dynamic work environment in Watford that fosters innovation and collaboration. With a strong commitment to employee development, competitive compensation, and a flexible benefits package, we empower our team to thrive both personally and professionally. Join us in our mission to tackle the world's most pressing health challenges while enjoying a supportive culture that values diversity and inclusion.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager Watford
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those at Medtronic. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulations. Show us you know your stuff about MHRA and HPRA – it’ll impress the hiring team and show you’re serious about the role.
✨Tip Number 3
Don’t just apply and wait! Follow up on your application through our website. A quick email or message can remind us of your enthusiasm and keep you on our radar.
✨Tip Number 4
Showcase your leadership skills! Be ready to discuss how you've developed teams or led projects in the past. We want to see how you can lead our Quality & Regulatory Affairs team to success!
We think you need these skills to ace Regulatory Affairs Manager Watford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in regulatory compliance and quality systems, especially within the medical device industry. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your leadership experience can benefit our UKI QRA team. Keep it engaging and relevant to the job description.
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've led teams or improved processes in previous roles. We love seeing quantifiable results that demonstrate your impact.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to us. Plus, we’re excited to see what you bring to the table!
How to prepare for a job interview at Medtronic
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the role, especially ISO 13485 and UK/EU regulatory requirements. Being able to discuss these confidently will show your expertise and readiness for the position.
✨Showcase Leadership Skills
Prepare examples of how you've led teams or projects in the past. Highlight your experience in developing people and driving compliance initiatives, as this role requires strong leadership and interpersonal skills.
✨Stay Updated on Industry Changes
Research recent changes in regulatory affairs that could impact the medical device industry. Being able to discuss these changes and their implications during the interview will demonstrate your proactive approach and analytical thinking.
✨Prepare for Scenario Questions
Anticipate scenario-based questions related to post-market surveillance and audits. Think through how you would handle specific situations, as this will showcase your problem-solving abilities and hands-on approach.
